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New treatment option for Refractory Lupus Nephritis
Official title Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.
ClinicalTrials.gov ID: NCT06947473
What this study is testing
What is umbilical cord blood CD19-BCMA CAR-T cells infusion?
umbilical cord blood CD19-BCMA CAR-T cells infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH receive umbilical cord blood CD19-BCMA CAR T cell therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 65
You may be able to join if
- 1\. Refractory lupus nephritis (LN): According to the 2019 American College of Rheumatology (ACR) criteria and the 2018 International Society of...
- Male or female patients aged 3-65 years old;
- Systemic lupus erythematosus that meets the 2019 American College of Rheumatology (ACR)/European Union of Rheumatology Associations (EULAR)...
- The result of the anti nuclear antibody (ANA) test is clearly positive, that is, the ANA titer is ≥ 1:80 (equivalent test result based on Hep-2...
- B cell CD19+expression and discontinuation of immunosuppressive agents for more than 1 week;
You likely can't join if
- 1\. Refractory lupus nephritis (LN):
- 1) Intracranial hypertension or cerebral consciousness disorders; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe...
- 15) people who were not successfully matched during the screening period; 16) Previously received CART treatment other than CD19-CART. 2. Primary...
- 1) PH caused by other reasons: portal hypertension, hereditary hemorrhagic telangiectasia, etc; Congenital heart disease; Suspicious drugs and...
- 1) Overlapping connective tissue diseases; Rheumatoid arthritis, systemic lupus erythematosus, or inflammatory myopathy 2) The clinical...
- 3) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis...
See the full eligibility criteria
- 1\. Refractory lupus nephritis (LN): According to the 2019 American College of Rheumatology (ACR) criteria and the 2018 International Society of Nephrology (ISN)/Society of Nephrology (RPS) criteria (see Appendix 3)...
- Male or female patients aged 3-65 years old;
- Systemic lupus erythematosus that meets the 2019 American College of Rheumatology (ACR)/European Union of Rheumatology Associations (EULAR) classification criteria (see Annex 5);
- The result of the anti nuclear antibody (ANA) test is clearly positive, that is, the ANA titer is ≥ 1:80 (equivalent test result based on Hep-2 immunofluorescence detection method or enzyme immunoassay method), and/or...
- B cell CD19+expression and discontinuation of immunosuppressive agents for more than 1 week;
- No severe allergic constitution;
- Physical condition score (ECOG) 0-2 points;
- Expected survival period ≥ 90 days;
- The people and/or their guardians are able to understand and willing to sign a written informed consent form; 2. Systemic sclerosis (SSc):
- The selected patient or their legal representative voluntarily signs the informed consent form.
- Age range: 6-65 years old (including 6 and 65 years old), gender is not limited.
- According to the SSc classification criteria proposed by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2013, the highest score under the same item, ≥ 9 points, can be...
- Or if one sufficient condition is met, that is, the skin of both fingers thickens and extends to the proximal end of the metacarpophalangeal joint, it can be directly classified as SSc. 3\. Primary Sjogren's syndrome...
- Diagnosed with primary Sjogren's syndrome according to the 2002 AECG classification criteria or the 2016 ACR/EULAR classification criteria
- Confirmed by right heart catheterization to meet the diagnostic criteria for PAH (as defined in the 2022 ESC/ERS guidelines for the diagnosis and treatment of pulmonary arterial hypertension):
- Resting mean pulmonary artery pressure (mPAP) ≥ 20mmHg;
- Pulmonary artery wedge pressure (PAWP) ≤ 15mmHg; ③ Resting pulmonary vascular resistance (PVR)\>2WU; (4) PAH did not reach the risk stratification of low-risk group patients. Low risk patients need to meet: ① WHO heart...
- 1\. Refractory lupus nephritis (LN):
- 1) Intracranial hypertension or cerebral consciousness disorders; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) Accompanied by other types of malignant tumors; 5)...
- 15) people who were not successfully matched during the screening period; 16) Previously received CART treatment other than CD19-CART. 2. Primary Sjogren's syndrome with pulmonary hypertension (pSS PAH):
- 1) PH caused by other reasons: portal hypertension, hereditary hemorrhagic telangiectasia, etc; Congenital heart disease; Suspicious drugs and toxins; Chronic hypoxic disease-related pulmonary hypertension: moderate or...
- 1) Overlapping connective tissue diseases; Rheumatoid arthritis, systemic lupus erythematosus, or inflammatory myopathy 2) The clinical manifestations can be explained by similar diseases of SSc, such as nephrogenic...
- 3) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline; 4)...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.